Food AllergyPhase 3NCT05678959
Long-term Extension Study of Ligelizumab in Food Allergy
A Phase 3 study testing Ligelizumab 120 mg and Ligelizumab 240 mg in people with Food Allergy, run by Novartis Pharmaceuticals at 49 sites in 9 countries.
Trial summary
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy. Read more about this study
- Who is it for?
- Ages 6 to 57 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Ligelizumab 120 mg and Ligelizumab 240 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 27 Apr 2023to 6 Mar 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 57 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit.
- Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy.
- Participants who were willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge).
- Participants who agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study.
- Participants who were able to safely continue into the study as judged by the investigator.
Who cannot join
- Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies.
- Development of a serious adverse event which was suspected to be related to the study treatment judged by the investigator during the core study.
- Development of uncontrolled asthma during the core study that compromised the safety of the participants judged by the investigator.
- Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator.
- Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion, should not participate in this extension study.
- Platelets <75,000/ul at end of treatment of the core study.
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
United States25 sites
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30342
UCHealth Outpatient Pavilion
Aurora, Colorado, 80045
Johns Hopkins Childrens Center
Baltimore, Maryland, 21287
Allervie Clinical Research
Birmingham, Alabama, 35209
Boston Childrens Hospital
Boston, Massachusetts, 02215
UBMD Pediatrics
Buffalo, New York, 14203
University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, 60611
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, 45229-3039
Asthma and Allergy Associates P C
Colorado Springs, Colorado, 80907
Unv of TX Southwestern Medical Center
Dallas, Texas, 75235
Texas Childrens Hospital
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Family Allergy and Asthma
Lousiville, Kentucky, 40217
Atlanta Allergy and Asthma Clinic
Marietta, Georgia, 30062
Northwell Health
New York, New York, 10028
Mt Sinai Medical Center
New York, New York, 10029-6574
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Allergy and Asthma Associates of Santa Clara Vally Center
San Jose, California, 95117
Allergy and Immunology Associates
Scottsdale, Arizona, 85251
Seattle Allergy and Asthma Rsch
Seattle, Washington, 98115
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida, 33613
Allergy and Asthma Clin Res Inc
Walnut Creek, California, 94598
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
Canada5 sites
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5
Novartis Investigative Site
Montreal, Quebec, H3T 1C5
Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Novartis Investigative Site
Québec, Quebec, G1V 4W2
Novartis Investigative Site
Toronto, Ontario, M3B 3S6
France4 sites
Novartis Investigative Site
Angers, France, 49933
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Toulouse, 31400
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Germany4 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Novartis Investigative Site
Frankfurt am Main, Hesse, 60596
Spain4 sites
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
Esplugues, Barcelona, 08950
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28040
Australia3 sites
Novartis Investigative Site
Brisbane, Queensland, 4101
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Parkville, Victoria, 3052
Japan2 sites
Novartis Investigative Site
Sagamihara, Kanagawa, 252-0392
Novartis Investigative Site
Setagaya-ku, Tokyo, 157-8535
About this study
Official title: A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
Read the detailed description
This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.
Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.
A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.
- Conditions
- Food Allergy
- Being tested
- Ligelizumab 120 mg, Ligelizumab 240 mg
- Keywords
- Food allergy, Peanut allergy, Oral food challenge (OFC), Immunoglobulin E (IgE), ligelizumab
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligelizumab 120 mgDrug
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks
Ligelizumab 240 mgDrug
2 injections of 1.0 mL ligelizumab every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ligelizumab 120 mg | Experimental | Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. Receives: Drug: Ligelizumab 120 mg |
| Ligelizumab 240 mg | Experimental | Participants received ligelizumab 240 mg every 4 weeks. Receives: Drug: Ligelizumab 240 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment.
Measured: Up to approximately 81 weeks
Secondary outcomes (7)
Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms
Assessed during an open-label oral food challenge (OFC). If missing Week 52-OFC assessments, Week 156-OFC assessments were performed within 380 days (inclusive) after first extension dose date and considered as Week 52-OFC assessments.
Measured: Up to approximately 97 weeks
Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug
TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment.
Measured: Up to approximately 81 weeks
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)
The FAQLQ-TF is a self-reported instrument designed for adolescents aged 13-17 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes three domains (emotional impact, allergen avoidance and dietary restrictions, and risk of accidental exposure). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge.
Measured: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)
The FAQLQ-AF is a self-reported instrument designed for adults aged 18-55 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes four domains (emotional impact, allergen avoidance and dietary restrictions, risk of accidental exposure, and food allergy-related health). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge.
Measured: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)
The FAIM-TF is a self-reported instrument designed for adolescents aged 13-17. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions. The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge.
Measured: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF)
The FAIM-AF is a self-reported instrument designed for adults aged 18-55. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. the range for each item and the total score is from 1 (minimum) to 7 (maximum). The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge.
Measured: Up to approximately 97 weeks
Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS)
The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It contains 8 scales and 2 component summary indices evaluating physical, social, and emotional functioning in addition to general health perceptions and mental health. PCS and MCS scores range from 0 to 100, with higher scores indicating better health outcomes.
Measured: Up to approximately 97 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start27 Apr 2023
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678959
- Sponsor's protocol ID
- CQGE031G12303B
- Other IDs
- 2022-502366-25-00
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2023
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
PubMed 38814736
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy
- ClinicalTrials.gov ID
- NCT05678959
- Acronym / sponsor ID
- CQGE031G12303B
- Conditions
- Food Allergy
- Keywords
- Food allergy, Peanut allergy, Oral food challenge (OFC), Immunoglobulin E (IgE), ligelizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
Detailed description
This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.
Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.
A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligelizumab 120 mg | Experimental | Drug: Ligelizumab 120 mgParticipants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. |
| Ligelizumab 240 mg | Experimental | Drug: Ligelizumab 240 mgParticipants received ligelizumab 240 mg every 4 weeks. |
Who may qualify
- Ages
- 6 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit.
- Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy.
- Participants who were willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge).
- Participants who agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study.
- Participants who were able to safely continue into the study as judged by the investigator.
Key exclusion criteria (6 listed)
- Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies.
- Development of a serious adverse event which was suspected to be related to the study treatment judged by the investigator during the core study.
- Development of uncontrolled asthma during the core study that compromised the safety of the participants judged by the investigator.
- Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator.
- Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion, should not participate in this extension study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligelizumab 120 mg1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks | Drug | Ligelizumab 120 mg |
| Ligelizumab 240 mg2 injections of 1.0 mL ligelizumab every 4 weeks | Drug | Ligelizumab 240 mg |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Up to approximately 81 weeks
TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment.
7 secondary outcomes
Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms
Time frame: Up to approximately 97 weeks
Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug
Time frame: Up to approximately 81 weeks
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)
Time frame: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)
Time frame: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)
Time frame: Up to approximately 97 weeks
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF)
Time frame: Up to approximately 97 weeks
Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS)
Time frame: Up to approximately 97 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38814736Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- A Pediatric Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ligelizumab 120 mg and Ligelizumab 240 mg in people with Food Allergy, run by Novartis Pharmaceuticals at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada, France, Germany, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: Up to approximately 81 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.